Form 8-K - Current report
November 09 2023 - 4:11PM
Edgar (US Regulatory)
false 0001708493 0001708493 2023-11-09 2023-11-09
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 9, 2023
Harpoon Therapeutics, Inc.
(Exact name of Registrant as Specified in Its Charter)
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Delaware |
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001-38800 |
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47-3458693 |
(State or Other Jurisdiction of Incorporation) |
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(Commission File Number) |
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(IRS Employer Identification No.) |
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611 Gateway Boulevard, Suite 400 South San Francisco, California |
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94080 |
(Address of Principal Executive Offices) |
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(Zip Code) |
(650) 443-7400
(Registrant’s Telephone Number, Including Area Code)
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instructions A.2. below):
☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
Common stock, par value $0.0001 per share |
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HARP |
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The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On November 9, 2023, Harpoon Therapeutics, Inc. (“Harpoon”) issued a press release announcing its financial results for the three and nine months ended September 30, 2023. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information in this Item 2.02 of this Form 8-K and the Exhibit 99.1 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Harpoon Therapeutics, Inc. |
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Date: November 9, 2023 |
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By: |
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/s/ Julie Eastland |
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Julie Eastland |
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President and Chief Executive Officer |
Exhibit 99.1
Harpoon Therapeutics Reports Third Quarter 2023 Financial Results and Provides Corporate Update
October 2023 financing funds late-stage clinical trials of HPN328 in multiple tumor types
Positive interim results from Phase 1/2 trial of T cell engager HPN328 in patients with small cell lung cancer (SCLC) and other
neuroendocrine tumor types presented at ESMO 2023
HPN328 Phase 2 monotherapy dose(s) selection on track for year-end 2023 for discussion with regulators in 1H 2024
Data update of ongoing HPN328 Phase 1/2
trial expected in 1H 2024
SOUTH SAN FRANCISCO, Calif., November 9, 2023 Harpoon Therapeutics,
Inc. (NASDAQ: HARP) (the Company), a clinical-stage immunotherapy company developing novel T cell engagers, today reported financial results for the third quarter ended September 30, 2023 and provided corporate updates.
Over the last several months, we have made important progress and positioned Harpoon for continued momentum ahead. During ESMO last month, we presented
the largest data set so far for HPN328 and are excited by the clinical benefit observed, particularly the response data in our 1 mg priming dose cohorts, from which we plan to select the recommended Phase 2 dose(s) by the of this year. The HPN328
interim update shows compelling activity with the potential for best-in-class efficacy as we select the optimized dose to study across multiple tumor types, including
small cell lung cancer, neuroendocrine prostate cancer, and other neuroendocrine neoplasms, said Julie Eastland, President and CEO of Harpoon Therapeutics. We look forward to meeting with the regulators in the first half of 2024 to
discuss our development plans. Additionally, our newly strengthened balance sheet allows us to continue executing toward multiple value-creating events.
Corporate Update
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In November, Harpoon regained compliance with all applicable continued listing standards of the Nasdaq Capital
Market. |
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In October, Harpoon completed a financing supported by a top-tier
investor syndicate for up to approximately $150 million including $100 million received at closing and up to $50 million in cash warrants. The financing extends the cash runway into 2026 assuming $50 million from future exercises
of cash warrants issued with the financing, and into the second half of 2025 with $100 million received at closing, excluding any future proceeds from the exercise of the cash warrants. |
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In August, Harpoons Board of Directors approved a reverse stock split of the Companys outstanding
common stock at a ratio of one-for-ten. The reverse split became effective September 1, 2023. |
Tri-specific T cell Activating Construct (TriTAC®) Platform
HPN328 (DLL3) Phase 1/2 trial in small cell lung cancer (SCLC), NEPC, and other
neuroendocrine neoplasms
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In October, Harpoon completed enrollment in the Phase 1 monotherapy dose escalation cohorts.
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In October, Harpoon reported favorable interim monotherapy data in a poster session at the European Society for
Medical Oncology (ESMO) in October in Madrid. The preliminary response data for all tumor types and patient cohorts treated with 1 mg priming dose was 35%, including three confirmed complete responses. In SCLC, the confirmed response rate was 32%,
with one confirmed complete response. In patients with other neuroendocrine tumor types, such as prostate cancer, small cell cervical, small cell bladder, and large cell lung cancer, the confirmed response rate was 42%, including two confirmed
complete responses. HPN328 was generally well tolerated across all dose cohorts; cytokine release syndrome (CRS) was the most common treatment-related adverse event (59%) and was primarily Grade 1 or 2. No discontinuations were observed for patients
with Grade 1 or 2 CRS. |
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In September, the first patients were dosed in the ongoing Phase 1/2 dose escalation trial evaluating combination
therapy of HPN328 with atezolizumab (Tecentriq®) in patients with SCLC. |
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Harpoon expects to identify the recommended Phase 2 dose(s) in the monotherapy setting by the end of 2023 for
discussion with regulators in the first half of 2024. |
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Phase 1 data update of the ongoing Phase 1/2 study is expected in the first half of 2024. |
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Harpoon is planning to conduct one or more Phase 2/3 trials starting in the second half of 2024, pending dose(s)
selection and discussions with regulators. |
HPN217 (BCMA) Phase 1 trial for relapsed, refractory multiple myeloma (RRMM)
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In November, an abstract detailing the results from the completed dose escalation portion, up to 24 mg, of the
Phase 1 study of HPN217 in patients with RRMM was accepted as an oral presentation at the upcoming 65th American Society of Hematology (ASH) Annual Meeting and Exposition being held December 9-12, 2023, in San
Diego. |
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In September, HPN217 demonstrated early and durable responses at the target dose of 12 mg in a Phase 1 trial for
RRMM. A 63% ORR was reported, and a manageable tolerability profile was observed with low rates of CRS (16%, all G1-2) and no ICANS. Results were reported in a poster presentation at the 30th International Myeloma Society (IMS) Annual Meeting in Athens, Greece. |
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In September, Harpoon announced the termination of the Development and Option Agreement, which granted AbbVie an
option to a worldwide, exclusive license to the HPN217 program. The program remains exclusively owned by Harpoon, and the Company plans to complete the ongoing Phase 1 trial. |
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Recommended Phase 2 regimen(s) expected to be identified by the end of 2023. |
Third Quarter 2023 Financial Results
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Harpoon ended the third quarter of 2023 with $31.6 million in cash, cash equivalents, short-term marketable
securities, compared to $53.1 million as of December 31, 2022. After the close of the third quarter, the Company entered into a securities purchase agreement for a PIPE financing that is expected to result in upfront gross proceeds of
approximately $100 million, with up to an additional approximately $50 million of gross proceeds upon cash exercise of warrants, before deducting placement agent fees and offering expenses. |
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Revenue for the third quarter ended September 30, 2023 was $4.5 million, compared to $13.6 million
for the third quarter ended September 30, 2022. For the nine months ended September 30, 2023, revenue was $33.3 million compared to $27.8 million for the nine months ended September 30, 2022. |
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Research and development (R&D) expense for the third quarter ended September 30, 2023 was
$12.3 million, compared to $21.0 million for the third quarter ended September 30, 2022. For the nine months ended September 30, 2023, R&D expense was $39.7 million compared to $62.4 million for the nine months
ended September 30, 2022. |
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General and administrative (G&A) expense for the third quarter ended September 30, 2023 was
$4.3 million, compared to $4.5 million for the third quarter ended September 30, 2022. For the nine months ended September 30, 2023, G&A expense was $12.3 million compared to $15.0 million for the nine months ended
September 30, 2022. |
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Impairment of long-lived assets charge for the three and nine months ended September 30, 2023 was zero and
$1.7 million compared to zero for the three and nine months ended September 30, 2022. The charge is due to subleasing all office and lab space at the Cove facility as part of Harpoons completed restructuring plan which required
reducing the carrying values of long-lived assets to their fair values. |
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Net loss attributable to common stockholders for the third quarter ended September 30, 2023 was
$1.8 million compared to a net loss attributable to common stockholders of $11.6 million for the third quarter ended September 30, 2022. Net loss attributable to common stockholders for the nine months ended September 30, 2023
was $12.1 million compared to $49.3 million for the nine months ended September 30, 2022. |
About Harpoon Therapeutics
Harpoon Therapeutics is a clinical-stage immunotherapy company developing a novel class of T cell engagers that harness the power of the
bodys immune system to treat patients suffering from cancer and other diseases. T cell engagers are engineered proteins that direct a patients own T cells to kill target cells that express specific proteins, or antigens, carried by the
target cells. Using its proprietary Tri- specific T cell Activating Construct (TriTAC®) platform, Harpoon is developing a pipeline of novel TriTACs
initially focused on the treatment of solid tumors and hematologic malignancies. Harpoon has also developed a proprietary ProTriTAC platform, which applies a prodrug concept to its TriTAC
platform to create a therapeutic T cell engager that remains inactive until it reaches the tumor. Harpoons third proprietary technology platform, extended release TriTAC-XR, is designed to mitigate cytokine release syndrome. For additional
information about Harpoon Therapeutics, please visit www.harpoontx.com.
Cautionary Note Regarding Forward-Looking Statements
Any statements in this press release about the Companys future expectations, plans and prospects, as well as any other statements regarding matters that
are not historical facts, may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties and actual results may differ
materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements about the therapeutic potential of our product candidates, the expected timing, progress, and results of the
Companys clinical trials and interactions with regulators, the association of interim clinical data and preclinical results with potential treatment outcomes, the Companys data presentation plans, the Companys cash sufficiency and
runway, including expected proceeds from warrant exercises , and other statements containing the words anticipates, believes, continue, expects, intends, look forward,
plans, toward, will and similar expressions. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or
impossible to predict and, in some cases, beyond the Companys control. These forward-looking statements are based upon the Companys current expectations and involve assumptions that may never materialize or may prove to be incorrect.
Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with market conditions.
These and other risks are described in additional detail in the Companys filings with the U.S. Securities and Exchange Commission (SEC). All forward-looking statements contained in this press release speak only as of the date hereof, and the
Company specifically disclaims any obligation to update any forward-looking statement, whether because of new information, future events or otherwise.
Contact:
Ana Kapor
investors@harpoontx.com
Harpoon Therapeutics, Inc.
Statement of Operations and Comprehensive Loss
(Unaudited)
(in
thousands, except share and per share amounts)
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For the Three Months Ended September 30, |
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For the Nine Months Ended September 30, |
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2023 |
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2022 |
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2023 |
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2022 |
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Revenue |
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Collaboration and license revenue |
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$ |
4,448 |
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$ |
13,617 |
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$ |
33,252 |
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$ |
27,826 |
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Total revenue |
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4,448 |
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13,617 |
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33,252 |
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27,826 |
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Operating expenses |
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Research and development |
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12,325 |
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20,977 |
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39,684 |
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62,446 |
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General and administrative |
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4,262 |
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4,529 |
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12,250 |
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14,993 |
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Impairment of long-lived assets |
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1,729 |
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Total operating expenses |
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16,587 |
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25,506 |
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53,663 |
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77,439 |
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Loss from operations |
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(12,139 |
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(11,889 |
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(20,411 |
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(49,613 |
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Interest income, net |
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480 |
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289 |
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1,520 |
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433 |
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Interest expense |
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(2,046 |
) |
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(3,744 |
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Other income (expense), net |
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11,903 |
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(40 |
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10,556 |
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(132 |
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Net loss attributable to common stockholders |
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(1,802 |
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(11,640 |
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(12,079 |
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(49,312 |
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Other comprehensive loss: |
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Net unrealized (loss) gain on marketable securities |
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(4 |
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28 |
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4 |
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19 |
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Comprehensive loss |
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$ |
(1,806 |
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$ |
(11,612 |
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$ |
(12,075 |
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$ |
(49,293 |
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Net loss attributable to common stockholders per share, basic and diluted |
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$ |
(0.46 |
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$ |
(3.52 |
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$ |
(3.17 |
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$ |
(14.95 |
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Weighted-average shares used in computing net loss per share, basic and diluted |
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3,947,995 |
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3,306,215 |
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3,807,955 |
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3,299,357 |
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Harpoon Therapeutics, Inc.
Selected Balance Sheet Data
(Unaudited)
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September 30, 2023 |
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December 31, 2022 |
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(in thousands) |
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Cash, cash equivalents and short-term marketable securities |
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$ |
31,608 |
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$ |
53,112 |
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Total assets |
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$ |
47,578 |
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$ |
73,729 |
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Total liabilities |
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$ |
43,037 |
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$ |
68,330 |
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Total stockholders equity |
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$ |
4,541 |
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$ |
5,399 |
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Harpoon Therapeutics (NASDAQ:HARP)
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From Apr 2024 to May 2024
Harpoon Therapeutics (NASDAQ:HARP)
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From May 2023 to May 2024